News about GMP/cGMP

ICH: Implementing Quality Paradigm

New GMP information about ICH meeting in Tallinn describes recent developments for the pharmaceutical industry.

The International Conference on Harmonisation (ICH) Steering Committee and its Expert Working Groups (EWGs) met in Tallinn, Estonia from 5 – 10 June, 2010.

Quality of Pharmaceuticals

This meeting was highlighted by major progress in the global implementation of the ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) in an integrated way. To this end the ICH Quality Implementation Working Group (IWG) held its first training workshop in Tallinn. The training consisted of a case study representing the different phases of the life cycle of a pharmaceutical product. The case study was followed by individual break-out sessions on design space, control strategy, quality risk management and pharmaceutical quality system.

Further progress was made on the harmonisation of pharmacopeial text in the three regions, which will reduce testing requirements for industry. Read the complete EDQM Press Release concerning the pharmacopoeia topic here. Two annexes for the Q4B Guideline (Evaluation and Recommendation of Pharmacopoeial Text for Use in the ICH Regions; Annex 11 on Capillary Electrophoresis and Annex 12 on Analytical Sieving) reached Step 4 and another 2 (Annex 13 on Bulk and Tapped Density and Annex 14 on Bacterial Endotoxin) reached Step 2.

The Q3D EWG began work on a guideline that will provide limits on Metal Impurities qualitatively and quantitatively in drug products and ingredients.

Non-Clinical Safety

The ICH Steering Committee approved the establishment of an EWG for a new multidisciplinary topic (M7) on Genotoxic Impurities. The guideline will describe the evaluation, qualification and control of these impurities in medicines during development and after licensing. The Steering Committee also approved the establishment of an EWG for a new safety topic on Photosafety Evaluation (S10). The aim is to provide harmonised guidance on timing and appropriateness of photosafety testing and assessment.

Clinical Safety and Efficacy

The E7 IWG completed a set of Questions and Answers (Q&As), addressing issues arising from the E7 guideline on Studies in Support of Special Populations: Geriatrics. The Q&As provide guidance on the appropriate representation of the geriatric population (including patients with concomitant therapies and co-morbidities) in the clinical development program to adequately characterise efficacy and safety in the geriatric population.

Next Meeting

The next ICH Steering Committee and its expert working groups meetings will be held in Fukuoka, Japan from 6-11 November, 2010.